药物洗脱支架与金属裸支架治疗金属裸支架内再狭窄。
Drug-eluting stents versus bare-metal stents for treatment of bare-metal in-stent restenosis.
机构信息
Department of Cardiovascular Medicine, Heart and Vascular Institute, Cleveland Clinic, 9500 Euclid Avenue, Cleveland, OH 44195, USA.
出版信息
Catheter Cardiovasc Interv. 2010 Aug 1;76(2):257-62. doi: 10.1002/ccd.22509.
OBJECTIVES
We compared the long-term outcomes of drug-eluting stents (DES) versus bare-metal stents (BMS) for treatment of bare-metal in-stent restenosis (ISR).
BACKGROUND
There are no randomized trials or observational studies directly comparing the safety and efficacy of DES versus BMS for treatment of bare-metal ISR.
METHODS
We examined data on all patients who underwent percutaneous coronary intervention (PCI) for ISR at Cleveland Clinic between 05/1999 and 06/2007. We compared the efficacy and safety of DES to BMS for treating bare-metal ISR. The primary end point was a composite of death, myocardial infarction (MI), or target lesion revascularization (TLR). The secondary endpoints were individual components of the primary endpoint.
RESULTS
Of the 931 patients identified over 8 years, 706 had bare-metal ISR and met our study criteria. Of the 706 patients with bare-metal ISR, 362 were treated with DES and 344 with BMS. There were 230 cumulative events for a median follow-up of 3.2 years. After adjusting for 27 variables, DES were associated with lower primary endpoint compared to BMS for treatment of bare-metal ISR (21% vs. 45%, adjusted hazard ratio [HR] 0.63; 95% confidence interval [CI], 0.42-0.95; P = 0.03). The individual secondary endpoint of death (8% vs. 24%, P = 0.005) favored DES, but MI (3% vs. 8%, P = 0.31), and TLR (13% vs. 20%, P = 0.23) failed to reach statistical significance.
CONCLUSIONS
In our multivariate analysis of patients with bare-metal ISR, DES use was associated with significantly lower death, MI, or TLR when compared to BMS.
目的
我们比较了药物洗脱支架（DES）与裸金属支架（BMS）治疗裸金属支架内再狭窄（ISR）的长期疗效。
背景
目前尚无直接比较 DES 与 BMS 治疗裸金属 ISR 的安全性和疗效的随机试验或观察性研究。
方法
我们分析了克利夫兰诊所 1999 年 5 月至 2007 年 6 月间所有接受经皮冠状动脉介入治疗（PCI）治疗 ISR 的患者的数据。我们比较了 DES 与 BMS 治疗裸金属 ISR 的疗效和安全性。主要终点是死亡、心肌梗死（MI）或靶病变血运重建（TLR）的复合终点。次要终点是主要终点的各个组成部分。
结果
在 8 年期间共确定了 931 例患者，其中 706 例患有裸金属 ISR 并符合我们的研究标准。在 706 例裸金属 ISR 患者中，362 例接受 DES 治疗，344 例接受 BMS 治疗。中位随访 3.2 年期间共发生 230 例累积事件。在调整了 27 个变量后，DES 治疗裸金属 ISR 的主要终点发生率低于 BMS（21% vs. 45%，调整后危险比[HR]0.63；95%置信区间[CI]0.42-0.95；P=0.03）。次要终点死亡（8% vs. 24%，P=0.005）倾向于 DES，但 MI（3% vs. 8%，P=0.31）和 TLR（13% vs. 20%，P=0.23）未达到统计学意义。
结论
在我们对裸金属 ISR 患者的多变量分析中，与 BMS 相比，DES 的使用与较低的死亡、MI 或 TLR 相关。
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